Sarepta will stop shipping Elevidys, Duchenne gene therapy

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54.

Sarepta Therapeutics said Monday evening it will pause all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, following a request by the Food and Drug Administration.

It’s a surprising reversal by Sarepta. The company had initially rejected the agency’s request, which was issued Friday. 

Shipments will halt by close of business Tuesday evening, the company said.